| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K921290 |
| Device Name |
INMAN MEDICAL OIL EMULSION DRESSING |
| Applicant |
| Inman Medical Corp. |
| 3815 E. Loop 820 S. |
|
Fort Worth,
TX
76119
|
|
| Applicant Contact |
GLENN CRUM |
| Correspondent |
| Inman Medical Corp. |
| 3815 E. Loop 820 S. |
|
Fort Worth,
TX
76119
|
|
| Correspondent Contact |
GLENN CRUM |
| Classification Product Code |
|
| Date Received | 03/11/1992 |
| Decision Date | 11/23/1992 |
| Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|